—
Source: Fox News
Summary
Moderna’s application for a new flu vaccine using mRNA technology was refused by the FDA due to a lack of an “adequate and well-controlled” study with a comparator arm. The FDA cited the need for a study that reflects the “best-available standard of care.” Moderna received a “refusal-to-file” letter from the FDA’s Center for Biologics Evaluation and Research. The company plans to engage with the FDA to understand the path forward. The decision comes amid increased scrutiny over vaccine approvals under Health Secretary Robert F. Kennedy Jr.
Our Reading
The advice sounds familiar.
The FDA’s decision to refuse Moderna’s application for a new flu vaccine using mRNA technology is not surprising given the controversy surrounding vaccine approvals under Health Secretary Robert F. Kennedy Jr.
Moderna’s application was rejected due to a lack of an “adequate and well-controlled” study with a comparator arm, citing the need for a study that reflects the “best-available standard of care.”
The company plans to engage with the FDA to understand the path forward, which may lead to changes in the study design or the introduction of new data.
This guidance has been heard before, as the FDA has previously rejected applications for new vaccines or therapies due to concerns over study design or data quality.
Original observation: The FDA’s decision to refuse Moderna’s application is a reminder that health guidance is not a permanent or absolute truth, but rather a constantly evolving process subject to revision and reinterpretation.
Author: Evan Null
